The Recall Desk
HighFDA (Devices)·Z-2029-2025·Announced 2025-07-02

[pending] GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound syst

Pending LLM rewrite. Source: FDA_DEVICE Z-2029-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.

The recalled product

Product
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
Manufacturer
GE Medical Systems China Co., Ltd.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI/DI 00195278722430
  • Lot/Serial Numbers: 6310028WX0
  • 6310008WX0
  • 6310041WX0
  • 6310017WX0
  • 6310031WX0
  • 6310044WX0
  • 6310024WX0
  • 6310038WX0
  • 6310040WX0
  • 6310019WX0
  • 6310018WX0
  • 6310023WX0
  • 6310033WX0
  • 6310012WX0
  • 6310026WX0
  • 6310020WX0
  • 6310032WX0
  • 6310014WX0
  • 6310021WX0

Distribution

Distribution scope not specified by the agency.

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